Method for aspirating a space within a body

ABSTRACT

Methods for aspirating a space within the body of a patient, such as the subdural space, including providing an evacuating port device having an evacuating lumen in fluid communication with the space in the body. A port aspiration device is mounted on the evacuating port device, creating fluid communication between an aspiration channel of the port aspiration device and the evacuating lumen. An instrument is positioned in the aspiration channel so that the instrument is capable of entering the evacuating lumen of the evacuating port device. The instrument can dispense medication and/or remove materials from the lumen or the space in the body. The evacuating port device can be mounted to a patient&#39;s skull.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 11/546,656and now U.S. Pat. No. 7,553,290, filed Oct. 12, 2006, which is acontinuation-in-part of U.S. application Ser. No. 09/633,573, filed Aug.4, 2000, which is a continuation-in-part of U.S. application Ser.29/105,951, filed Jun. 4, 1999 and now U.S. Pat. No. D435,291; thedisclosures of these patent applications are incorporated by referenceherein in their entireties.

BACKGROUND

The present disclosure relates to systems for removing fluids from thesubdural region of a patient and more particularly pertains to a newsubdural evacuating port aspiration system for aspirating an evacuatingport device useful for removing subdural fluid accumulations in a mannerthat is minimally invasive and promotes decompression, expansion, andrecovery of the brain.

The subdural space of the human head is the space located between thebrain and the lining of the brain, which is referred to as the duramater (hereinafter referred to as the “dura”). Hemorrhages on thesurface of the brain, for example, may cause a condition known as asubdural hematoma. The subdural hemorrhages may have a number of causes.For example, elderly persons may be more susceptible to subduralhemorrhages because as the brain ages it tends to become atrophic andthe subdural space between the brain and the dura gradually enlarges.Bridging veins between brain and dura frequently stretch and rupture asa consequence of relatively minor head injuries, thus giving rise to acollection of blood in the subdural space. Further, severe lineardeceleration of the brain can result in the brain moving excessivelywith respect to the dura, often causing rupture of the bridging veins orthe blood vessels on the surface of the brain, which can in turn causesubdural hemorrhages in the “normal”, young, and otherwise healthybrain.

These subdural blood collections can be classified as acute subduralhematomas, subacute subdural hematomas, and chronic subdural hematomas.Acute subdural hematomas, which are associated with major cerebraltrauma, generally consist primarily of fresh blood. Subacute subduralhematomas are generally associated with less severe injuries than thoseunderlying the acute subdural hematomas. Chronic subdural hematomas aregenerally associated with even less severe, or relatively minor,injuries. The chronic subdural hematomas tend to be less dense liquidconsisting of very diluted blood.

Another condition involving a subdural collection of fluid is a hygroma,which is a collection of cerebrospinal fluid (sometimes mixed withblood) beneath the dura, usually in an encapsulation or cyst.

One form of treatment for acute subdural hematomas is the performance ofa craniotomy operation. This operation entails the removal (witheventual replacement) of a large portion of the skull, opening of thedura, and evacuation of the collection of blood. The craniotomyfrequently necessitates the placement of a subdural drain, whichcomprises a tube extending through the hole created by the crainiotomyand into the subdural space for removing any additional accumulation ofblood or fluid. The craniotomy is a highly invasive procedure thatgenerally involves significant risk to the patient and an extendedrecovery period.

Since the subacute and chronic types of subdural hematomas primarilycomprise collections of liquid, the treatment may range from theperformance of a craniotomy to the use of a burr hole. The burr holeoperation generally comprises boring in the skull a hole that is smallerthan the portion of skull removed in a craniotomy. The burr holegenerally has a diameter of about 14 to 18 mm. Through the burr hole,extensive washing of the subdural space may be carried out.

Frequently, a drain needs to be left in place through the burr hole,with the end of the drain being in communication with the surface of thebrain in order to allow for postoperative drainage of any furtheraccumulations of fluid. Again, the patient is exposed to a fairlyinvasive procedure and a relatively long recovery period.

The aforementioned drains are typically used in combination with theapplication of negative pressure through the tube of the drain. Thetypical level of the negative pressure applied by the drains frequentlycauses further hemorrhage of the brain, especially if the end of thetube should come in contact with the surface of the brain. Further,recurrence of subdural hematomas and hygromas is quite common in chroniccases as the brain generally fails to expand to fill the enlargedsubdural space created by the collection of fluid. If the subdural spaceremains enlarged after removal of the fluid, additional fluid tends tocollect in the enlarged subdural space. The aforementioned treatmenttechniques do not actively contribute to re-expansion of the brainwithin the dura, and therefore do little to prevent the re-accumulationof fluid in the enlarged subdural space.

Furthermore, blood clots or other obstructions occasionally block thepassages of devices (such as drains) that are used to remove fluids fromthe skull.

The known devices typically do not address the need to clear theseblockages from the passages or the affected inside the skull, or evenperiodically administer substances to the affected area inside theskull, without having to remove the devices from the skull.

The subdural evacuating port system according to the present disclosuresubstantially departs from the conventional concepts and designs andmethods of the prior art, and in so doing provides an apparatus andmethod primarily developed for the purpose of removing subdural fluidaccumulations in a manner that is minimally invasive and promotesdecompression, expansion, and recovery of the brain.

SUMMARY

In view of the foregoing disadvantages inherent in the known techniquesand systems for removing fluids from the subdural region of a patientnow present in the prior art, the present disclosure provides a newsubdural evacuating port system with a device and method of use whereinthe same can be utilized for removing subdural fluid accumulations in amanner that is minimally invasive and promotes the decompression,expansion, and recovery of the brain.

The disclosure includes a procedure for treating substantially liquidsubdural fluid collections in a manner that is minimally invasive anddoes not involve touching the brain. Significantly, the procedures ofthe disclosure promote brain expansion within the dura by creating ahomogeneous, negative pressure throughout the subdural space from whichthe fluid collection has been removed.

The disclosure is especially effective when used on patients having asubdural space filled with fluid that is substantially liquid withoutsignificant coagulation of the fluid, including acute patients that aretaking anticoagulants to enhance the fluidity of the matter that hasaccumulated in the subdural space.

The disclosure contemplates a kit for evacuating a collection of fluidfrom a subdural space of a patient having a scalp. The kit may include asubdural evacuating port device having a proximal end and a distal end.The subdural evacuating port device has a tubular portion with a lumenextending between the proximal and distal ends. An exterior surface ofthe proximal end of the tubular portion has self-tapping threads formedthereon for cutting threads into a skull. Retaining means on theexterior surface of the tubular portion adjacent to the distal end areprovided for engaging an interior surface of a conduit with a flexiblewall to releasably retain the conduit on the distal end of the tubularportion. A pair of wings extend outwardly from the tubular portion insubstantially opposite directions. The kit also includes means forperforming placement of the subdural evacuating port device in thepatent. The means for performing placement of the subdural evacuatingport device may include means for preparing an operative site on thescalp of the patient. The means for performing placement of the subduralevacuating port device may include means for opening an operative siteon the patient. The means for performing placement of the subduralevacuating port device may include means for establishing an operativearea on the patient. The kit may also include packaging for removablysecuring other elements of the kit. The means for performing placementof the subdural evacuating port device may include means for maintainingan operative area on the patient.

In another aspect of the disclosure, a subdural evacuation portaspiration system is disclosed for permitting aspiration of a subduralevacuation port device that defines an evacuation lumen. The evacuationport aspiration system may comprise an evacuation port aspiration devicefor facilitating aspiration of the evacuation port device when the portaspiration device is mounted on the evacuation port device. The portaspiration device defines an aspiration channel, and further comprises amounting portion that is configured to mount on the evacuation portdevice. The mounting portion defines a first portion of the aspirationchannel. The port aspiration device further comprises an aspirationportion for receiving an aspiration device, and that defines a secondportion of the aspiration channel. The port aspiration device stillfurther comprises a negative pressure connection portion for connectingto a negative pressure source, and defines a third portion of theaspiration channel.

In still another aspect of the disclosure, a method of aspirating aspace within the body of a patient is disclosed, and may includeproviding a subdural evacuating port device having an evacuating lumenin fluid communication with the space in the body, and mounting a portaspiration device on the evacuating port device. Mounting of the portaspiration device may include creating fluid communication between anaspiration channel of the port aspiration device and the evacuatinglumen of the evacuating port device. The method may further includepositioning an instrument in the aspiration channel of the portaspiration device so that the instrument is capable of entering theevacuating lumen of the evacuating port device.

There has thus been outlined, rather broadly, features of the disclosurein order that the detailed description thereof that follows may bebetter understood, and in order that the present contribution to the artmay be better appreciated. There are additional features of thedisclosure that will be described hereinafter and which will form thesubject matter of the claims appended hereto.

In this respect, before explaining at least one embodiment of thedisclosure in detail, it is to be understood that the disclosure is notlimited in its application to the details of construction and to thearrangements of the components set forth in the following description orillustrated in the drawings. The disclosure is capable of otherembodiments and of being practiced and carried out in various ways.Also, it is to be understood that the phraseology and terminologyemployed herein are for the purpose of description and should not beregarded as limiting.

As such, those skilled in the art will appreciate that the conception,upon which this disclosure is based, may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the present disclosure. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present disclosure.

For a better understanding of the disclosure, its operating advantagesand the specific objects attained by its uses, reference should be madeto the accompanying drawings and descriptive matter in which there areillustrated preferred embodiments of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be better understood and objects other than those setforth above will become apparent when consideration is given to thefollowing detailed description thereof. Such description makes referenceto the annexed drawings wherein:

FIG. 1 is a schematic perspective view of a subdural evacuating portdevice in accordance with principles of the present disclosure.

FIG. 2 is a schematic side view of a drill bit useful in the techniquesof the present disclosure.

FIG. 3 is a schematic side view of a bulb useful in the techniques ofthe present disclosure.

FIG. 4 is a schematic end view of the subdural evacuating port device ofFIG. 1.

FIG. 5 is a schematic sectional view of the subdural evacuating portdevice of FIG. 1.

FIG. 6 is a schematic perspective view of a retractor useful in thetechniques of the present disclosure.

FIG. 7 is a schematic sectional view of a portion of a patient's skulland brain area with the subdural evacuating port device of FIG. 1mounted on the skull.

FIG. 8 is a schematic perspective view of an evacuating port aspirationsystem in accordance with principles of the present disclosure,including an evacuating port aspiration device mounted on the evacuatingport device of FIG. 1.

FIG. 9 is a schematic exploded perspective view of the system shown inFIG. 8.

FIG. 10 is a schematic perspective view of the evacuating portaspiration device of FIG. 8.

FIG. 11 is a schematic sectional view of the evacuating port aspirationdevice of FIG. 8.

FIG. 12 is a schematic sectional view of the evacuating port aspirationsystem of FIG. 8 mounted on a patient's skull.

FIG. 13 is a schematic perspective view of another evacuating portaspiration device in accordance with principles of the presentdisclosure including a length adjustment structure.

FIG. 14 is a schematic sectional view of the evacuating port aspirationdevice of FIG. 13.

FIG. 15 is a schematic sectional view of another evacuating portaspiration system in accordance with principles of the presentdisclosure including the evacuating port aspiration device of FIG. 13.

FIG. 16 is a schematic perspective view of another evacuating portaspiration device in accordance with principles of the presentdisclosure.

FIG. 17 is a schematic perspective view of a portion of anotherevacuating port aspiration system in accordance with principles of thepresent disclosure.

FIG. 18 is a schematic sectional view of the system of FIG. 17 with aremovable, adjustable cap.

DETAILED DESCRIPTION

With reference now to the drawings, and in particular to FIGS. 1 through18 thereof, a new subdural evacuating port system and subduralevacuating port aspiration system embodying the principles and conceptsof the present disclosure will be described.

As best illustrated in FIGS. 1 through 7, one system in accordance withaspects of the present disclosure generally includes a subduralevacuating port device 10, and contemplates a kit for evacuating acollection of fluid from a subdural space of a patient that incorporatesthe subdural evacuating port device. The system also contemplates amethod for utilizing the subdural evacuating port device and elements ofthe kit for removing fluid from the subdural space while facilitatingthe recovery of the patient's brain.

Elements useful in practicing the disclosure include the subduralevacuating port device 10, a drill device 12, a drill bit 14 formounting on the drill device, a stop collar 16 for mounting on the drillbit, a retractor device 18, a negative pressure source 20, and a conduit22.

The drill device 12 is provided for rotating the drill bit 14. The drillbit 14 is mountable on the drill device 12 in a suitable manner, such asby an adjustable chuck assembly 13. The chuck assembly 13 of the drilldevice 12 is most preferably rotated by manual means (e.g., turned bythe surgeon's hand), but optionally the chuck assembly 13 may be drivenby motorized means.

The drill bit 14 is adapted for removably mounting on the drill device12, and the drill bit 14 can be sized for creating a opening of asuitable size in the skull of the patient, as will be discussed ingreater detail below. Illustratively, the drill bit 14 is formed of astainless steel material. The stop collar 16 can be provided forselectively limiting the maximum penetration of the tip of the drill bit14 into the skull of the patient. The stop collar 16 can be selectivelylockable in a variety of longitudinal positions along the length of thedrill bit 14 depending upon the depth of penetration needed to producean opening through the skull without injuring the brain.

The stop collar 16 is provided with a channel for receiving a portion ofthe drill bit 14, and the stop collar 16 has a set screw 17 forextending into the channel and abutting against the drill bit 14 forlocking the stop collar 16 in a selected longitudinal position.Illustratively, one suitable material for the stop collar 16 is a nylon,such as DELRIN.

The retractor device 18 is provided for holding back the edges of anincision made through the scalp of the patient. The retractor device 18is useful for reducing the possibility of contact between the drill bit14 and the scalp when the drill bit 14 is inserted through the incisionfor boring into the skull, and thus reduces any damage resulting fromsuch contact. In some embodiments, the retraction device is of the typeknown as a “Holzheimer” retractor (see FIG. 6). The “Holzheimer”retractor generally has two arms 56, 58 that are joined together atproximal ends of the arms to form an apex 60. The arms 56, 58 extendaway from the apex 60 and terminate at free ends 62, 64 of the arms 56,58. Preferably, the free ends 62, 64 of the arms 56, 58 are spaced suchthat the arms 56, 58 form a substantially V-shaped structure. A lockingmember 66 may be included on the retractor for selectively locking thearms at a desired spacing. The “Holzheimer” retractor 18 has a loweredge 68 for inserting into the incision. A tab 70, 72 may be provided oneach of the arms 56, 58 adjacent to the lower edge 68 at a locationseparated from the apex 60 of the clip. The tabs 70, 72 preferably lodgethemselves below the outer surface of the scalp to help hold the clip inplace with respect to the incision during the period when the incisionneeds to be held open. Optionally, but less preferably, retraction ofthe scalp may be performed by other known types of surgical retractors,such as, for example, a “Mastoid” retractor, a “Gelpi” retractor, or a“Heiss” retractor.

The negative pressure device 20 is provided for creating a uniformnegative pressure condition in the subdural space of the patient. Thenegative pressure device exerts a suction for imparting a uniformpartial vacuum in the subdural space. The magnitude of the negativepressure condition created is relatively low for exerting a gentlesuction in the subdural space. The substantial uniformity of thenegative pressure is considered important for promoting the gradualre-expansion of the brain in the subdural space. The magnitude of thenegative pressure exerted by a suitable negative pressure source isapproximately 0.8 inch to 1 inch of mercury (Hg) with respect toatmospheric pressure. It may be appreciated that a lower level (e.g.,less than 0.8 inches of mercury) of negative pressure may be used,although the effectiveness of the fluid removal may be reduced. Whilerelatively higher levels of negative pressure may be used (such as up toapproximately 1.2 inches of mercury), significantly higher levels ofnegative pressure can hamper the recovery of the brain and theassociated tissues, by, for example, not allowing the brain to fullyre-expand to its condition prior to the fluid accumulating in thesubdural space. The relatively low level of negative pressure permitsthe negative pressure condition to be maintained in the subdural spacefor a relatively extended period of time for removing any furthercollection of fluid, as well as promoting a gradual expansion of thebrain in the subdural space during the healing process.

A useful negative pressure source is a device commonly referred to as aJackson-Pratt bulb (see FIG. 3). The Jackson-Pratt bulb 20 has aninterior and a pair of openings 24, 26. More particularly, the bulb 20has a primary opening 24 and a secondary opening 26, and each opening24, 26 extends between the interior and an exterior of the bulb. A checkvalve (not shown) is provided on the bulb 20 in communication with theprimary opening 24 for resisting exit of fluid (e.g., gas or liquid)from the interior to the exterior of the bulb through the primaryopening while permitting fluid flow into the interior through theprimary opening. A cap 28 may be provided for selectively closing thesecondary opening 26 of the bulb 20 thus requiring any fluid enteringthe interior to enter through the primary opening 24.

The conduit 22 may be provided for fluidly connecting the subduralevacuating port device 10 with the negative pressure source 20.Preferably, the conduit 22 connects the primary opening 24 of theJackson-Pratt bulb 20 with the subdural evacuating port device. Theconduit 22 has first 30 and second 32 ends, and the first end 30 isremovably connectable to the subdural evacuating port device 10 and thesecond end 32 is removably connectable to the primary opening 24 of theJackson-Pratt bulb 20. The conduit 22 may comprise flexible tubing ofthe type commonly used for draining fluids from the body, such as, forexample, tubing formed from a silicone material. Illustratively, alength of tubing between approximately 2.4 and 3 feet (approximately 75cm and 90 cm) is suitable.

A feature of the disclosure is the subdural evacuating port device 10for penetrating the skull of the patient. The port device 10 includes asubstantially tubular portion 40 with a lumen 42 that extends between aproximal end 36 and a distal end 38 of the port device 10. An exteriorsurface 44 of the proximal end 36 of the tubular portion 40 ispreferably provided with self-tapping threads 46 formed thereon forcutting threads into the skull of the patient as the proximal end 36 isinserted into an opening 8 in the patient's skull 2 and the port device10 is rotated in the opening. Illustratively, a longitudinal groove 48may extend through the self-tapping threads 46 to produce thread cuttingsurfaces on the exterior surface 44. An exterior surface 44 of thedistal end 38 of the tubular portion 40 preferably has a plurality ofannular barbs 50 formed thereon for retaining the conduit 22 on thedistal end 38.

The subdural evacuating port device 10 includes a pair of wings 52, 54extending outwardly from the tubular portion 40 which facilitate fingerrotation of the tubular portion 40 in the opening 8 of the skull 2during the threading of the opening by the self-tapping threads 46 ofthe port device 10. The wings 52, 54 extend in substantially oppositedirections for enhancing finger grippability of the wings. The wings 52,54 may be mounted on the tubular portion 40 at a location substantiallymedially between the proximal 36 and distal 38 ends of the tubularportion 40, between the self-tapping threads 46 and the annular barbs50.

In one illustrative embodiment of the port device 10, the diameter ofthe exterior surface 44 of the tubular portion 40 measures approximately6 mm. The lumen 42 has a diameter of approximately 3.8 mm. The length ofthe tubular portion 40 from the distal end 38 to the proximal portion 36is approximately 45 mm. The width between the tips of the wings 52, 54is approximately 23 mm, and the width of the wings 52, 54 isapproximately 5 mm in some constructions. The self-tapping threads 46may extend approximately 10 mm from the proximal end 36, and the annularbarbs 50 may extend approximately 15 mm from the distal end 38.

The method aspects of the disclosure permits evacuation of a collectionof fluid from the subdural space within the skull 2 of a patient. One ofthe initial acts of the method includes determining the region of thescalp 1 of the patient that is adjacent to the location of thecollection of fluid in the subdural space. Preferably, the region islocated on the patient's scalp 1 where the collection of fluid has thegreatest dimension or measurement in the subdural space of the skull 2.The location of the greatest dimension of the fluid collection may bedetermined by performing an imaging study of the head of the patientusing, for example, computerized tomography or magnetic resonanceimaging to determine the extent of the collection of fluid. Once thegreatest dimension of the collection of fluid is determined, thelocation of the opening to be made through the skull 2 to the subduralcavity is selected on the scalp 1 at a substantially central locationcorresponding to the greatest dimension of the collection of fluid.

The scalp 1 of the patient may be infiltrated with an anesthetic such asby injecting the anesthetic into the scalp 1 in the region where thesubdural collection of fluid has the greatest dimension. Illustratively,the anesthetic may be lidocaine or epinephrine, or other suitableanesthetic.

An incision 6 is created in the scalp 1 to expose the bone of the skull2 of the patient. The incision 6 extends through the scalp 1, thesubcutaneous tissue, the galea, and the periosteum. The retractor device18 is introduced into the incision 6 for holding the scalp 1 adjacent tothe incision away from the operating area. An opening 8 is created inthe skull 2 of the patient using the drill bit 14 mounted in the drilldevice 12. The size of the opening 8 formed in the skull may beapproximately 3 to 8 mm in diameter. The opening 8 in the skull can beapproximately 5 to 7 mm in diameter. The appropriate size opening can beapproximately 6 mm in diameter. The size of the drill bit 14 is suchthat it will create a suitable size opening in the skull.

The dura 3 may then be penetrated by incising the dura of the patientusing, for example, a unipolar cautery device. The underlying membranesmay be transected with the unipolar cautery device.

Fluid that has collected in the subdural space is removed from the spacethrough the incision in the dura 3. This removal can be performedthrough the use of the subdural evacuating port device 10. The proximalend 36 of the subdural evacuating port device 10 is introduced into theopening 8 in the skull 2. The port device 10 is rotated in the opening 8such that the self-tapping threads 46 engage the sides of the opening 8and pull the proximal end 36 into the opening 8 and secure the portdevice 10 against unintentional withdrawal of the device 10 from theopening 8. The dura 3 may be penetrated by the proximal end 36 of theport device 10 for placing the lumen 42 in fluid communication with thesubdural area, and any collection of fluid in a subdural space.

A substantially uniform negative pressure condition is created in thesubdural space. This negative pressure condition can be created throughthe lumen 42 of the subdural evacuating port device 10 of thedisclosure. The first end 30 of the conduit 22 is connected to thedistal end 38 of the subdural evacuating port device, with the annularbarbs 50 retaining the conduit 22 on the port device 10. The second end32 of the conduit 22 is connected to the negative pressure source. Theprimary opening 24 of a Jackson-Pratt bulb 20 is connected to the secondend 32 of the conduit 22. To produce the negative pressure condition inthe conduit 22 and the lumen 42 of the port device 10, the Jackson-Prattbulb 20 is compressed (such as by hand gripping of the bulb) with thecap 28 removed from the secondary opening 26 to expel as much air fromthe bulb as possible. The cap 28 is then placed over the secondaryopening 26, and the expansion of the resilient bulb from the collapsedcondition produces a negative pressure condition in the interior of thebulb as well as the conduit 22 and the lumen 42 of the port device 10.

The negative pressure condition created in the lumen 42 of the portdevice 10 tends to draw fluid collected in the subdural space throughthe lumen 42 and into the conduit 22 and into the interior of the bulb20. The fluid collected in the interior of the bulb 20 may beperiodically emptied from the bulb, and the negative pressure conditionmay be reapplied to the subdural space through the port device 10 usingthe bulb 20. The negative pressure condition may be removed whendrainage from the subdural space is no longer observed, or the desiredre-expansion of the brain in the subdural space has occurred, or as isdetermined to be medically advisable. To remove the subdural evacuatingport device 10, the device 10 is rotated (e.g., using the wings 52, 54)such that the threads 46 move the port device 10 out of the opening 8.

In another aspect of the disclosure, a subdural evacuation portaspiration system 80 (shown in FIGS. 8 through 18) permits aspiration ofthe evacuation port device 10 as well as an internal body space that isin communication with the port device 10. As described above, theevacuation port device 10 defines the evacuating lumen 42 that is influid communication with the subdural space of the patient for thepurposes of relieving pressure in the subdural space, as well as otherpurposes permitted by the port device 10. In some circumstances, it maybe desirable to access the lumen 42 of the port device 10 while aconduit remains connected to the port device 10 and withoutsignificantly altering the negative pressure condition in the subduralspace. The access may be for the purposes of, for example, clearingblood clots from the evacuating lumen 42 or the area just outside of thelumen 42, or for administering drugs or other medicaments to thesubdural area via the port device 10.

The subdural evacuation portion aspiration system 80 includes anevacuation port aspiration device 82 that permits access to theevacuating lumen 42 and thus permits aspiration of the evacuation portdevice 10 when the port aspiration device 82 is mounted on theevacuation port device 10 (see FIGS. 8 through 10). The port aspirationdevice 82 defines an aspiration channel 84 (see FIGS. 11 and 12), andmay be configured to create fluid communication between the aspirationchannel 84 and the evacuation port lumen 42 when the port aspirationdevice 82 is mounted on the evacuation port device 10. The portaspiration device 82 may thereby become the conduit for receiving, forexample, a needle or other instrument that is inserted into the portlumen 42 and optionally into the subcranial space of the patient, suchas the subdural space.

In greater detail, the port aspiration device 82 may comprise a mountingportion 86 that is configured to mount on the evacuation port device 10.The mounting portion 86 may define a first portion 88 of the aspirationchannel 84, and may include a socket 90 configured to receive a portionof the evacuation port device 10, such as, for example, the distal end36 of the port device 10. The socket 90 may be in fluid communicationwith the first portion 88 of the aspiration channel 84. The mountingportion 86 terminates at a first end 92 of the port aspiration device82. The mounting portion 86 may include a first perimeter wall 93 whichmay define the socket 90 so that the socket 90 comprises a portion ofthe aspiration channel 84. The socket 90 may have an enlarged widthcompared to a width of the first portion 88 of the aspiration channel84.

The mounting portion 86 may also include a mounting structure 94 that ispositioned on the socket 90 for removably mounting the distal end 38 ofthe tubular portion 40 of the evacuation port device 10 on the socket90. The mounting structure 94 may be configured to removably grip thedistal end of the evacuation port device 10, such as by engaging orgripping the retaining structure 50 of the evacuation port device 10(although other manners of engagement may be employed). In oneembodiment of the disclosure, the mounting structure 94 comprises acompressible material 96 positioned in the socket 90 for engaging theretaining structure 50 of the evacuation port device 10. Thecompressible material 96 may line a portion of an interior surface ofthe socket 90. The compressible material 96 may, for example, beconfigured in a hollow tubular shape, and may be substantiallycylindrical. The compressible material 96 may be sized so that insertionof the distal end of the evacuation port device 10 at least partiallycompresses the compressible material 96 and creates a substantially airtight and fluid tight relationship between the lumen 42 of the portdevice 10 and the aspiration channel 84 of the port aspiration device82. It will be recognized by those skilled in the art that otherequivalent mounting structure designs may also be employed.

The port aspiration device 82 may also include an aspiration portion 100for receiving an aspiration device, such as, for example, a needle orother instrument. The aspiration portion 100 may define a second portion102 of the aspiration channel 84. The second portion 102 of theaspiration channel 84 may be axially aligned with the first portion 88of the aspiration channel 84 such that the first and second portions 88,102 of the aspiration channel 84 are configured to receive a needle (orother elongate instrument) therethrough. The aspiration portion 100 mayterminate in a second end 104 of the aspiration device 82. Theaspiration portion 100 may comprise a second perimeter wall 106 that isconnected to the first perimeter wall 93.

A closing structure 108 may be provided on the aspiration portion 100 ofthe device 82 for closing the second portion 102 of the aspirationchannel 84 (see FIG. 11). The closing structure 108 may close theaspiration channel 84 in an air tight and fluid tight manner. Theclosing structure 108 may extend across the aspiration channel 84. Theclosing structure 108 may be mounted on the second perimeter wall 106 ofthe aspiration portion, and may be seated in and extend into an annulargroove 110 formed in the second perimeter wall 106. The closingstructure 108 may be puncturable or be otherwise penetrated by a needleor other instrument. The closing structure 108 may be configured toreseal (or substantially reseal) itself after a puncturing needle iswithdrawn from puncture of the closing structure. In some embodiments,the closing structure 108 may comprise a septum such as is employed onbottles holding liquid medicines, which are drawn from the bottle usinga hypodermic needle. This closure or septum may comprise an elastomericmaterial, such as, for example, synthetic or natural rubber.

The port aspiration device 82 may further comprise a negative pressureconnection portion 112 for connecting to a negative pressure source,such as through a conduit of the type described previously in thisspecification. The negative pressure connection portion 112 may define athird portion 114 of the aspiration channel 84. The third portion 114 ofthe aspiration channel 84 may extend along an axis that is skewed withrespect to an axis of the first portion 88 of the aspiration channel.The negative pressure connection portion 112 may terminate in a thirdend 115 of the aspiration device 82. It should be recognized thatalthough the illustrative embodiment includes a single negative pressureconnection portion 112, two or more connection portions may be includedon the port aspiration device 82, and the one or more connectionportions are not necessarily limited to the purpose of providing anegative pressure connection.

In greater detail, the negative pressure connection portion 112 maycomprise a third perimeter wall 116 that has an exterior surface 118.The third perimeter wall 116 may be connected to the first 93 and second106 perimeter walls. The negative pressure connection portion 112 mayfurther comprise a retaining structure 120 for engaging a conduitmounted on the negative pressure connection portion 112. The retainingstructure 120 may include at least one annular barb formed on theexterior surface 118 adjacent to the third end 115 of the aspirationdevice 82 to engage the interior surface of a conduit having a flexiblewall, to thereby releasably retain the conduit on the third end 115 ofthe port aspiration device 82.

In some embodiments of the port aspiration device 82, the distancebetween the first end 92 and the second end 104 of the port aspirationdevice 82 is a defined distance, so that the healthcare provider is ableto calculate the approximate depth of penetration of the needle or otherinstrument into the skull cavity when the needle or instrument of aknown length is fully inserted into the port aspiration device 82. Theport aspiration device 82 may be provided with different defineddistances between the first 92 and second 104 ends so that the desiredlength of the port aspiration device may be selected.

Optionally, as illustrated in FIG. 10 of the drawings, an indicia may bemarked on the port aspiration device 82 to indicate the distance betweenthe first end 92 and the second end 104 of the device 82 so that theuser of the device 82 is able to know the defined distance without, forexample, having to measure the distance. As noted above, knowledge ofthe distance between the first 92 and second 104 ends can assist indetermining the length of the needle to use with the port aspirationdevice 82 or the position of a limiting structure 122 that will now bedescribed.

In other embodiments of the port aspiration device 82, a limitingstructure 122 may be provided on the device 82 that is capable ofadjustably limiting a depth of insertion of a needle (or otherinstrument) into the evacuation port device 10 through the aspirationdevice 82 (see FIG. 12). Illustratively, the limiting structure 122 maycomprise a stop collar 124 that is mountable on a needle (or otherinstrument) at an adjustable distance from a tip of the needle such thatinsertion of the needle brings the collar 124 into contact with thesecond end 104 of the port aspiration device 82 to limit furtherinsertion of the needle into the aspiration channel 84.

In still other embodiments, the limiting structure 122 may comprise anadjustment structure 126 for adjusting an effective length of themounting 86 and aspiration 100 portions of the port aspiration device82. Illustratively, the adjustment structure 126 comprises an adjustablecollar element 128 mounted on the aspiration portion 100 of theaspiration device 82 (see FIGS. 13 through 16). The adjustable collarelement 128 may define a lumen 130 in fluid communication with theaspiration channel 84. The adjustable collar element 128 may comprise acollar 132, with the lumen 130 extending through the collar 132, and acolumn 134 mounted on the collar 132. The lumen 130 extends through thecolumn 134. The column 134 may be at least partially inserted into theaspiration portion 100. The column 134 and the aspiration portion 100may be coupled together in a manner that permits the degree of extensionof the collar 132 from the aspiration portion 100 to be adjusted. In atleast one embodiment, the column 134 has an exterior surface 136 that isthreaded. The threaded exterior surface 136 of the column 134 may beengaged with a threaded interior surface 138 of the second portion 102of the aspiration channel 84 such that rotation of the column 134 in afirst rotational direction moves the collar 132 away from the aspirationportion 100 and rotation of the column 134 in a second rotationaldirection moves the collar toward the aspiration portion 100. Thus,rotation of the collar 132 and column 134 causes a change in theeffective length of the aspiration device between the first and secondends. The closing structure 108 may be mounted on the column 134 to thusclose the lumen 130 of the adjustable collar element 128, and thus theclosing structure would not be present on the second portion 102 of theaspiration channel 84. Although a threaded coupling has been described,other manners of coupling the collar 132 and the column 134 to theaspiration portion 100 may be employed without departing from thedisclosure.

Optionally, a length indication device 140 may be provided forindicating the effective length of the port aspiration device 82 (seeFIG. 16). The length indication device 140 may include graduationsmarked thereon that may be calibrated to indicate the distance betweenthe first 92 and second 104 ends, or the total effective length ofaspiration channel 84 of the aspiration device 82 and the lumen 42 ofthe evacuation port 10. The length indication device 140 may includestructure 142 for interlocking with the collar 132 to lock the collarand column 134 against rotation once the desired adjustment has beenachieved. In other embodiments of the disclosure, graduations or lengthindicating indicia may be marked on the portion aspiration device (suchas on the exterior surface 136 of the column 134) so that the distancebetween the ends 92, 104 is discernable from the graduations as thedegree of extension is adjusted.

It should be realized that even though the evacuation port device 10 andthe port aspiration device 82 as separate or separable parts is highlyuseful, the structural aspects of the port device 10 and the aspirationdevice 82 may also be implemented as a unified part that does not permitseparation of the elements from each other. Thus, in patientapplications for the evacuation port device where it is known thataccess to the subdural space will be needed while the port device is inplace to, for example, apply medicine to the area or clear a blood clot,a combination structure of the devices such as is shown in FIGS. 17 and18 of the drawings may be employed. Such an embodiment, designated bythe reference number 150, may include any of the features describedabove, but may omit the structures employed to removably mount the portaspiration device to the evacuating port device. Further, the embodiment150 may includes a unified body member 162 that may include structuresthat generally correspond to a tubular portion 154 and wings 156, 157 ofthe evacuating port aspect, and an aspiration portion 158 and a negativepressure portion 160 of the port aspiration aspect. The unifiedembodiment 150 may also include a cap member 162 that is removablymounted on the aspiration portion 158. A closing structure 164 may bemounted on the cap member 152 so that the closing structure 164 is thusremovable from the unified body member 152. The cap member 162 may beremovably mounted on the body member 152 by means of threads, such asexterior threads formed on the body member and interior threads formedon the cap member. In some embodiments, the exterior threads on the bodymember 152 may be compatible with existing or standardized intravenous(IV) equipment to permit connection of IV equipment to the body member152. The threaded mounting of the cap member 162 provides the benefit ofadjustability of the overall length of the unified body member 152between a first end 166 and a second end 168 of the body member 152, thesignificance of which has been discussed previously in this description.Other structures may be employed to secure the cap member 162 on thebody member 152, or the cap member 162 may be omitted and the closingstructure 164 may be positioned directly on the body member 156.

Another aspect of the disclosure is directed to a method of aspirating asubdural space within the skull of a patient, or other space in the bodyin which the evacuating port device 10 is mounted. The method may beuseful when a blood clot or other accumulation of matter has becomelodged in, or is otherwise obstructing, the evacuating lumen 42 of theport device 10. Such obstructions may also occur in the subdural spacejust outside the evacuating lumen 42, such as when an agglomeration toolarge to pass through the evacuating lumen is drawn by the negativepressure toward the port device 10. The obstruction may then be removedby aspiration or by dissolution. Optionally, medicines or other fluidsmay be applied to the subdural space by means of a needle using the portaspiration and the evacuating port devices, or an integral combinationthereof.

The steps involved in positioning and placing the evacuating port device10 have been outlined previously, and the description of the method ofaspiration will commence from the point where the evacuating port device10 has been installed on the patient. If a conduit 22 has been connectedto the port device 10 such as at the distal end 36 of the tubularportion 40, an end of the conduit 22 is disconnected from the end of thetubular portion 40 to thereby free the distal end 30 of the port device10. The port aspiration device 82 is then mounted on the evacuating portdevice 10, which may include creating a fluid communication between anaspiration channel 84 of the port aspiration device 82 and theevacuating lumen 42 of the evacuating port device 10. To accomplishthis, the end 36 of the tubular portion 40 of the evacuating port device10 may be inserted into the socket 90 formed by the mounting portion 86of the port aspiration device 82. The end of the conduit 22 may bereconnected to the negative pressure connection portion 112 of the portaspiration device 82.

In some embodiments of the port aspiration device 82, an effectivelength of the aspiration device 82 between the first end 92 and thesecond end 104 may be adjusted. The adjustment may be effected in amanner suitable for the particular structure, such as in theillustrative embodiment, by rotating the adjustable collar element 128mounted on the aspiration portion 100 to selectively extend or retractthe adjustable collar 132 with respect to the aspiration portion of theport aspiration device 82. The effective length or distance between thefirst 92 and second 104 ends may be adjusted to affect the distance ordegree to which the instrument or needle may be inserted into or throughthe port aspiration device 82 and the evacuating device 10, andtherefore into the subdural space. The degree of penetration isdependent upon the effective length of the aspiration device 82 and thelength of the needle. Optionally, the degree of penetration by theneedle of known length, or the effective length of the aspiration device82, may be adjusted according to a marking viewed on the lengthindication device 140.

In other embodiments of the disclosure, the method may include limitingthe depth of penetration of the needle into the port aspiration device82 by adjusting the position of the stop collar 124 on the needleitself.

An instrument, such as a hypodermic needle, may be positioned in theaspiration channel 84 of the port aspiration device 82. The needle maybe inserted into the aspiration channel 84 through the aspirationportion 100 of the aspiration device. The needle may be inserted throughthe closing structure 108 in the aspiration channel 84 of the portaspiration device 82. The needle may continue through the evacuationlumen 42 of the evacuating port device 10. Once the end of the needlehas reached the evacuating lumen 42, it may be used to remove anobstruction in the lumen 42 or in the subdural space, as well as todeliver medicine or other fluids to the subdural space.

Finally, it should be appreciated from the foregoing description that,except when mutually exclusive, the features of the various embodimentsdescribed herein may be combined with features of other embodiments asdesired while remaining within the intended scope of the disclosure.

With respect to the above description then, it is to be realized thatthe optimum dimensional relationships for the parts of the disclosure,to include variations in size, materials, shape, form, function andmanner of operation, assembly and use, are deemed readily apparent toone skilled in the art, and all equivalent relationships to thoseillustrated in the drawings and described in the specification areintended to be encompassed by the present disclosure.

Therefore, the foregoing is considered as illustrative only of theprinciples of the disclosure. Further, since numerous modifications andchanges will readily occur to those skilled in the art, it is notdesired to limit the disclosure to the exact construction and operationshown and described, and accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of thedisclosure.

1. A method of aspirating a space within the body of a patient,comprising: providing a subdural evacuating port device having anevacuating lumen in fluid communication with the space in the body;mounting a port aspiration device on the evacuating port device,including creating fluid communication between an aspiration channel ofthe port aspiration device and the evacuating lumen of the evacuatingport device; and positioning an instrument in the aspiration channel ofthe port aspiration device so that the instrument is capable of enteringthe evacuating lumen of the evacuating port device.
 2. The method ofclaim 1, wherein mounting includes inserting an end of a tubular portionof the evacuating port device into a socket formed by a mounting portionof the port aspiration device so that the evacuating port device is atleast partially inserted into the aspiration channel.
 3. The method ofclaim 1, wherein positioning the instrument includes inserting a needleinto the aspiration channel of the port aspiration device and into theevacuating lumen of the evacuating port device.
 4. The method of claim1, wherein positioning the instrument includes inserting the instrumentthrough a closing structure in the aspiration channel of the portaspiration device.
 5. The method of claim 1, additionally includingadjusting an effective length of the port aspiration device betweenfirst and second ends of the port aspiration device.
 6. The method ofclaim 5, wherein adjusting the effective length includes rotating anadjustable collar element mounted on the aspiration portion toselectively extend or retract the adjustable collar with respect to theaspiration portion of the port aspiration device.
 7. The method of claim6, wherein adjusting the effective length includes aligning theadjustable collar with a selected marking on a length indication deviceincluding indicia indicating the effective length of the port aspirationdevice at various degrees of extension of the collar.
 8. The method ofclaim 1, additionally including disconnecting an end of a conduit fromthe evacuating port device and connecting the end of the conduit to anegative pressure connection portion of the port aspiration device. 9.The method of claim 1, additionally including: mounting a rigid tubularportion of the evacuation port device into a hole in a skull of apatient.
 10. The method of claim 9, wherein mounting the rigid tubularportion includes forming threads in a skull of the patient with rotationof the rigid tubular portion.
 11. The method of claim 1, wherein theaspiration channel includes a first portion, a second portion, and athird portion, the second and third portions diverging from one anotherin extension from the first portion, and further wherein upon mountingof the port aspiration device on the evacuating port device, the firstportion, the second portion, and the evacuating lumen combine to rigidlydefine a common, linear central axis.